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Effects of Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors

Primary Purpose

Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Natural supplement containing chlorogenic acid and luteolin

Placebo (without any active ingredients)

About this trial

This is an interventional supportive care trial for Metabolic Syndrome focused on measuring metabolic parameters, cardio-metabolic parameters

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women aged >18 years with the metabolic syndrome (as defined by the international criteria: Alberti KG, et al. Circulation. 2009; 120: 1640-5);
BMI> 25 kg/m^2;
Subjects able to swallow whole tablets;
Informed consent obtained prior to any study-related activities.

Exclusion Criteria:

Pregnancy or willingness to become pregnant;
Severe liver dysfunction (ALT >2.5 times upper limit of normal);
Severe renal failure (eGFR<60 mL/min/1.73 m2 using the MDRD formula);
Severe infections at the discretion of the investigator (such as HIV, HBV and HCV);
History or presence of malignant neoplasms within the last 5 years.

Sites / Locations

University Hospital of Palermo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dietary Supplement

Placebo

Arm Description

50 subjects with the metabolic syndrome receiving natural supplement containing chlorogenic acid and luteolin (450 mg/die)

50 subjects with the metabolic syndrome receiving placebo (without any active ingredients)

Outcomes

Primary Outcome Measures

Effect of natural supplement on metabolic parameters including body weight and Body Mass Index (BMI)

Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including body weight (kg) and height (m) that will be combined to report BMI in kg/m^2.

Effect of natural supplement on metabolic parameters including waist circumference

Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including waist circumference (cm).

Effect of natural supplement on metabolic parameters including plasma lipids

Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol HDL-C) (mmol/l), while low-density lipoprotein cholesterol (LDL-C) will be calculated using the Friedewald formula.

Effect of natural supplement on metabolic parameters including glucose metabolism parameters

Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma glycemia (mmol/l).

Effect of natural supplement on metabolic parameters including plasma insulinemia and HOMA (homeostatic model assessment) index

Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma insulinemia (pmol/L) that with glycemia will be combined to report HOMA index.

Secondary Outcome Measures

Effect of natural supplement on cardio-metabolic parameters including plasma cytokines

Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including plasma cytokines (inflammatory markers and adipokines) (pg/ml), that will be assessed using available enzyme-linked immunosorbent assay (ELISA) kits.

Effect of natural supplement on cardio-metabolic parameters including plasma lipoproteins

Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including atherogenic lipoproteins as well as the analysis of the full spectrum of lipoprotein subclasses by gel electrophoresis.

Effect of natural supplement on cardio-metabolic parameters including subclinical atherosclerosis

Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including subclinical atherosclerosis assessed by carotid intima-media thickness (CIMT) (mm).

Effect of natural supplement on cardio-metabolic parameters including fatty liver index

Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including fatty liver index, a noninvasive method used for steatosis detection and quantification.

Full Information

NCT ID

NCT03444558

First Posted

June 5, 2017

Last Updated

October 23, 2018

Sponsor

University of Palermo

Collaborators

University of Catania

1. Study Identification

Unique Protocol Identification Number

NCT03444558

Brief Title

Effects of Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors

Official Title

Effect of a Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

February 28, 2018 (Actual)

Study Completion Date

February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Palermo

Collaborators

University of Catania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Clinical trial about beneficial effects of natural ingredient containing chlorogenic acid and luteolin on liver health and conditions related to liver (such as metabolic syndrome) for general body health.

Detailed Description

This is one randomized, double-blind, placebo-controlled study. The purpose of the present study is to evaluate and/or elucidate the role of the natural supplement, containing chlorogenic acid (10-12%) and luteinyl-7-glucoside (2-4%), on cardio-metabolic risk factors. The research hypothesis is to evaluate whether natural supplement containing chlorogenic acid and luteolin (Puraltilix, BIONAP SRL, Catania, Italy) may improve several cardio-metabolic parameters in subjects with the metabolic syndrome. All subjects will be evaluated at baseline and after 6 months of treatment (with natural supplement or placebo).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metabolic Syndrome

Keywords

metabolic parameters, cardio-metabolic parameters

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

placebo-controlled study

Masking

ParticipantInvestigator

Masking Description

double-blind study

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dietary Supplement

Arm Type

Experimental

Arm Description

50 subjects with the metabolic syndrome receiving natural supplement containing chlorogenic acid and luteolin (450 mg/die)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

50 subjects with the metabolic syndrome receiving placebo (without any active ingredients)

Intervention Type

Dietary Supplement

Intervention Name(s)

Natural supplement containing chlorogenic acid and luteolin

Intervention Description

50 eligible subjects will receive natural supplement as the oral pills at a fixed dose of 1 pill/day (450 mg/day) for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.

Intervention Type

Other

Intervention Name(s)

Placebo (without any active ingredients)

Intervention Description

50 eligible subjects will receive placebo (without any active ingredients) at a fixed dose of 1 pill/day for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.

Primary Outcome Measure Information:

Title

Effect of natural supplement on metabolic parameters including body weight and Body Mass Index (BMI)

Description

Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including body weight (kg) and height (m) that will be combined to report BMI in kg/m^2.

Time Frame